Effectiveness of a symptom-clinic intervention delivered by general practitioners with an extended role for people with multiple and persistent physical symptoms in England: the Multiple Symptoms Study 3 pragmatic, multicentre, parallel-group, individually randomised controlled trial.

BACKGROUND: People with multiple and persistent physical symptoms have impaired quality of life and poor experiences of health care. We aimed to evaluate the effectiveness of a community-based symptom-clinic intervention in people with multiple and persistent physical symptoms, hypothesising that this symptoms clinic plus usual care would be superior to usual care only. METHODS: The Multiple Symptoms Study 3 was a pragmatic, multicentre, parallel-group, individually randomised controlled trial conducted in 108 general practices in the UK National Health Service in four regions of England between Dec 6, 2018, and June 30, 2023. Participants were individually randomised (1:1) to the symptom-clinic intervention plus usual care or to usual care only via a computer-generated, pseudo-random list stratified by trial centre. Allocation was done by the trial statistician and concealed with a centralised, web-based randomisation system; masking participants was not possible due to the nature of the intervention. The symptom-clinic intervention was a sequence of up to four medical consultations that aimed to elicit a detailed clinical history, fully hear and validate the participant, offer rational explanations for symptoms, and assist the participant to develop ways of managing their symptoms; it was delivered by general practitioners with an extended role. The primary outcome was Patient Health Questionnaire-15 (PHQ-15) score 52 weeks after randomisation, analysed by intention to treat. The trial is registered on the ISRCTN registry (ISRCTN57050216). FINDINGS: 354 participants were randomly assigned; 178 (50%) were assigned to receive the community-based symptoms clinic plus usual care and 176 (50%) were assigned to receive usual care only. At the primary-outcome point of 52 weeks, PHQ-15 scores were 14·1 (SD 3·7) in the group receiving usual care and 12·2 (4·5) in the group receiving the intervention. The adjusted between-group difference of -1·82 (95% CI -2·67 to -0·97) was statistically significantly in favour of the intervention group (p<0·0001). There were 39 adverse events in the group receiving usual care and 36 adverse events in the group receiving the intervention. There were no statistically significant between-group differences in the proportion of participants who had non-serious adverse events (-0·03, 95% CI -0·11 to 0·05) or serious adverse events (0·02, -0·02 to 0·07). No serious adverse event was deemed to be related to the trial intervention. INTERPRETATION: Our symptom-clinic intervention, which focused on explaining persistent symptoms to participants in order to support self-management, led to sustained improvement in multiple and persistent physical symptoms. FUNDING: UK National Institute for Health and Care Research.

Persistent physical symptoms: definition, genesis, and management.

Persistent physical symptoms (synonymous with persistent somatic symptoms) is an umbrella term for distressing somatic complaints that last several months or more, regardless of their cause. These symptoms are associated with substantial disability and represent a major burden for patients, health-care professionals, and society. Persistent physical symptoms can follow infections, injuries, medical diseases, stressful life events, or arise de novo. As symptoms persist, their link to clearly identifiable pathophysiology often weakens, making diagnosis and treatment challenging. Multiple biological and psychosocial risk factors and mechanisms contribute to the persistence of somatic symptoms, including persistent inflammation; epigenetic profiles; immune, metabolic and microbiome dysregulation; early adverse life experiences; depression; illness-related anxiety; dysfunctional symptom expectations; symptom focusing; symptom learning; and avoidance behaviours, with many factors being common across symptoms and diagnoses. Basic care consists of addressing underlying pathophysiology and using person-centred communication techniques with validation, appropriate reassurance, and biopsychosocial explanation. If basic care is insufficient, targeted psychological and pharmacological interventions can be beneficial. A better understanding of the multifactorial persistence of somatic symptoms should lead to more specific, personalised, and mechanism-based treatment, and a reduction in the stigma patients commonly face.

Stigmatisation in medical encounters for persistent physical symptoms/functional disorders: Scoping review and thematic synthesis.

OBJECTIVE: To conduct a scoping review of stigma in medical encounters for persistent physical symptoms and functional disorders (PPS/FD). Stigma is a social attribute that links a person to an undesirable characteristic. It has been extensively studied in relation to mental illness but less so in relation to PPS/FD. METHODS: We followed PRISMA-ScR reporting guidelines for scoping reviews. Searches for were designed using the SPIDER tool. We used descriptive and thematic analysis. RESULTS: The searches identified 68 articles, of which 32 were eligible for inclusion. 31 out of the 32 studies used a qualitative methodology. 8 studies used an explicit definition of stigma, of which 6 used the Goffman (1963) definition. Only 2 studies directly examined clinical consultations, the remainder relied on recalled accounts by patients or professionals. Descriptive analysis identified the focus of the studies included: patient-physician interaction (n = 13); health care professionals' perceptions (n = 7); experiences of illness/stigma (n = 6); broader meaning of illness (n = 3); and patients' experiences of stigma in health care consultations (n = 3). CONCLUSION: Patients experience stigmatisation in consultations for a wide range of PPS/FD. This suggests the presence of structural stigmatisation. PRACTICE IMPLICATIONS: There is a need for effective stigma reduction strategies in consultations about persistent physical symptoms.

Identifying models of care to improve outcomes for older people with urgent care needs: a mixed methods approach to develop a system dynamics model.

Background: We aimed to understand urgent and emergency care pathways for older people and develop a decision support tool using a mixed methods study design. Objective(s), study design, settings and participants: Work package 1 identified best practice through a review of reviews, patient, carer and professional interviews. Work package 2 involved qualitative case studies of selected urgent and emergency care pathways in the Yorkshire and Humber region. Work package 3 analysed linked databases describing urgent and emergency care pathways identifying patient, provider and pathway factors that explain differences in outcomes and costs. Work package 4 developed a system dynamics tool to compare emergency interventions. Results: A total of 18 reviews summarising 128 primary studies found that integrated social and medical care, screening and assessment, follow-up and monitoring of service outcomes were important. Forty patient/carer participants described emergency department attendances; most reported a reluctance to attend. Participants emphasised the importance of being treated with dignity, timely and accurate information provision and involvement in decision-making. Receiving care in a calm environment with attention to personal comfort and basic physical needs were key. Patient goals included diagnosis and resolution, well-planned discharge home and retaining physical function. Participants perceived many of these goals of care were not attained. A total of 21 professional participants were interviewed and 23 participated in focus groups, largely confirming the review evidence. Implementation challenges identified included the urgent and emergency care environment, organisational approaches to service development, staff skills and resources. Work package 2 involved 45 interviews and 30 hours of observation in four contrasting emergency departments. Key themes relating to implementation included: intervention-related staff: frailty mindset and behaviours resources: workforce, space, and physical environment operational influences: referral criteria, frailty assessment, operating hours, transport. context-related links with community, social and primary care organisation and management support COVID-19 pandemic. approaches to implementation service/quality improvement networks engaging staff and building relationships education about frailty evidence. The linked databases in work package 3 comprised 359,945 older people and 1,035,045 observations. The most powerful predictors of four-hour wait and transfer to hospital were age, previous attendance, out-of-hours attendance and call handler designation of urgency. Drawing upon the previous work packages and working closely with a wide range of patient and professional stakeholders, we developed an system dynamics tool that modelled five evidence-based urgent and emergency care interventions and their impact on the whole system in terms of reducing admissions, readmissions, and hospital related mortality. Limitations: Across the reviews there was incomplete reporting of interventions. People living with severe frailty and from ethnic minorities were under-represented in the patient/carer interviews. The linked databases did not include patient reported outcomes. The system dynamics model was limited to evidence-based interventions, which could not be modelled conjointly. Conclusions: We have reaffirmed the poor outcomes frequently experienced by many older people living with urgent care needs. We have identified interventions that could improve patient and service outcomes, as well as implementation tools and strategies to help including clinicians, service managers and commissioners improve emergency care for older people. Future work: Future work will focus on refining the system dynamics model, specifically including patient-reported outcome measures and pre-hospital services for older people living with frailty who have urgent care needs. Study registrations: This study is registered as PROSPERO CRD42018111461. WP 1.2: University of Leicester ethics: 17525-spc3-ls:healthsciences, WP 2: IRAS 262143, CAG 19/CAG/0194, WP 3: IRAS 215818, REC 17/YH/0024, CAG 17/CAG/0024. Funding: This project was funded by the National Institute for Health and Care Research (NIHR) Health and Social Care Delivery Research programme [project number 17/05/96 (Emergency Care for Older People)] and will be published in full in Health and Social Care Delivery Research; Vol. 11, No. 14. See the NIHR Journals Library website for further project information.

Many older people attending emergency care have poor outcomes; this project aimed to: describe best practice in emergency care understand how best practice might be delivered describe outcomes from emergency care, and synthesise this information in a computer simulation tool that can help teams decide which interventions might work best in their setting. The existing literature showed that holistic interventions (caring for the whole person), spanning emergency and community care, designed with the needs of older people in mind, work best. We checked these findings with front line clinicians, who agreed, but identified that implementing best practice in the emergency department was challenging. Limitations included the emergency department environment itself and the lack of staff with the right skillset. We also asked older people and their carers who had recently received emergency care what mattered. They prioritised basic needs such as comfort, communication, and timely care. They also stated that getting better, maintaining their usual level of function, and getting home safely were important outcomes. We then analysed data that linked together ambulance, emergency department, and hospital care in Yorkshire and Humber from 2011­17 for over 1 million emergency department attendances and hospital admissions. We found a novel and accurate predictor of long emergency department waits and hospital admission: the level of urgency according to the ambulance call handler. Drawing upon all the above and guided by a wide range of patient and professionals, we developed a computer model which allows emergency care teams to simulate different best practice emergency department interventions and estimate the impact on reducing admissions, readmissions, and hospital mortality. In summary, we have reaffirmed the poor outcomes experienced by many older people with urgent care needs. We have identified interventions that could improve patient and service outcomes, as well as implementation tools to help including clinicians, hospital managers and funders transform emergency care for older people.

Did the evidence-based intervention (EBI) programme reduce inappropriate procedures, lessen unwarranted variation or lead to spill-over effects in the National Health Service?

BACKGROUND: Health systems are under pressure to maintain services within limited resources. The Evidence-Based Interventions (EBI) programme published a first list of guidelines in 2019, which aimed to reduce inappropriate use of interventions within the NHS in England, reducing potential harm and optimising the use of limited resources. Seventeen procedures were selected in the first round, published in April 2019. METHODS: We evaluated changes in the trends for each procedure after its inclusion in the EBI's first list of guidelines using interrupted time series analysis. We explored whether there was any evidence of spill-over effects onto related or substitute procedures, as well as exploring changes in geographical variation following the publication of national guidance. RESULTS: Most procedures were experiencing downward trends in the years prior to the launch of EBI. We found no evidence of a trend change in any of the 17 procedures following the introduction of the guidance. No evidence of spill-over increases in substitute or related procedures was found. Geographic variation in the number of procedures performed across English CCGs remained at similar levels before and after EBI. CONCLUSIONS: The EBI programme had little success in its aim to further reduce the use of the 17 procedures it deemed inappropriate in all or certain circumstances. Most procedure rates were already decreasing before EBI and all continued with a similar trend afterwards. Geographical variation in the number of procedures remained at a similar level post EBI. De-adoption of inappropriate care is essential in maintaining health systems across the world. However, further research is needed to explore context specific enablers and barriers to effective identification and de-adoption of such inappropriate health care to support future de-adoption endeavours.

Recognition, explanation, action, learning: Teaching and delivery of a consultation model for persistent physical symptoms.

OBJECTIVE: To describe the teaching and delivery of an extended consultation model designed for clinicians to use with patients with persistent physical symptoms and functional disorders. The model is underpinned by current scientific knowledge about persistent physical symptoms and the communication problems that arise in dealing with them. METHODS: Process evaluation of training and delivery of the Recognition, Explanation, Action, Learning (REAL) model within the Multiple Symptoms Study 3: a randomised controlled trial of an extended-role GP "Symptoms Clinic". Evaluation used clinician and patient interviews and consultation transcripts. RESULTS: 7 GPs were trained in the intervention and 6 of them went on to deliver the REAL model in Symptoms Clinics either face-to-face or online. The Symptoms Clinic provided a set of 4 extended consultations to approximately 170 patients. Evaluation of training indicated that there was a considerable load in terms of new knowledge and skills. Evaluation of delivery found clinicians could adapt the model to individual patients while maintaining a high level of fidelity to its core components. CONCLUSION: REAL is a teachable consultation model addressing specific clinical communication issues for people with persistent physical symptoms. PRACTICE IMPLICATIONS: REAL enables clinicians to explain persistent physical symptoms in a beneficial way.

Syrian hamster convalescence from prototype SARS-CoV-2 confers measurable protection against the attenuated disease caused by the Omicron variant.

The mutation profile of the SARS-CoV-2 Omicron (lineage BA.1) variant posed a concern for naturally acquired and vaccine-induced immunity. We investigated the ability of prior infection with an early SARS-CoV-2 ancestral isolate (Australia/VIC01/2020, VIC01) to protect against disease caused by BA.1. We established that BA.1 infection in naïve Syrian hamsters resulted in a less severe disease than a comparable dose of the ancestral virus, with fewer clinical signs including less weight loss. We present data to show that these clinical observations were almost absent in convalescent hamsters challenged with the same dose of BA.1 50 days after an initial infection with ancestral virus. These data provide evidence that convalescent immunity against ancestral SARS-CoV-2 is protective against BA.1 in the Syrian hamster model of infection. Comparison with published pre-clinical and clinical data supports consistency of the model and its predictive value for the outcome in humans. Further, the ability to detect protection against the less severe disease caused by BA.1 demonstrates continued value of the Syrian hamster model for evaluation of BA.1-specific countermeasures.

What influences GPs' use of pelvic examination? A qualitative investigation in primary care.

BACKGROUND: Omission of pelvic examination (PE) has been associated with diagnostic delay in women diagnosed with gynaecological cancer. However, PEs are often not carried out by GPs. AIM: To determine the perceptions of GPs about the role of PEs, the barriers to and facilitators of PEs, and GPs' experience of PEs in practice. DESIGN AND SETTING: Qualitative semi-structured interview study conducted in one health board in Scotland (mixed urban and rural) with an approximate population of 500 000. METHOD: Interviews were conducted face-to-face or by telephone between March and June 2019. Framework analysis used the COM-B behaviour change model concepts of capability, opportunity, and motivation. RESULTS: Data was compatible with all three domains of the COM-B framework. Capability related to training in and maintenance of skills. These went beyond carrying out the examination to interpreting it reliably. Opportunity related to the clinical environment and the provision of chaperones for intimate examination. Interviewees described a range of motivations towards or against PEs that were unrelated to either capability or opportunity. These all related to providing high-quality care, but this was defined in different ways: 'doing what is best for the individual', 'doctors examine', and 'GPs as pragmatists'. CONCLUSION: GPs' reasons for carrying out, or not carrying out, PEs in women with symptoms potentially indicating cancer are complex. The COM-B framework provides a way of understanding this complexity. Interventions to increase the use of PEs, and critics of its non-use, need to consider these multiple factors.

Examining the effect of interventions in emergency care for older people using a system dynamics decision support tool.

BACKGROUND: Rising demand for Emergency and Urgent Care is a major international issue and outcomes for older people remain sub-optimal. Embarking upon large-scale service development is costly in terms of time, energy and resources with no guarantee of improved outcomes; computer simulation modelling offers an alternative, low risk and lower cost approach to explore possible interventions. METHOD: A system dynamics computer simulation model was developed as a decision support tool for service planners. The model represents patient flow through the emergency care process from the point of calling for help through ED attendance, possible admission, and discharge or death. The model was validated against five different evidence-based interventions (geriatric emergency medicine, front door frailty, hospital at home, proactive care and acute frailty units) on patient outcomes such as hospital-related mortality, readmission and length of stay. RESULTS: The model output estimations are consistent with empirical evidence. Each intervention has different levels of effect on patient outcomes. Most of the interventions show potential reductions in hospital admissions, readmissions and hospital-related deaths. CONCLUSIONS: System dynamics modelling can be used to support decisions on which emergency care interventions to implement to improve outcomes for older people.

Factors associated with longer wait times, admission and reattendances in older patients attending emergency departments: an analysis of linked healthcare data.

BACKGROUND AND OBJECTIVE: Care for older patients in the ED is an increasingly important issue with the ageing society. To better assess the quality of care in this patient group, we assessed predictors for three outcomes related to ED care: being seen and discharged within 4 hours of ED arrival; being admitted from ED to hospital and reattending the ED within 30 days. We also used these outcomes to identify better-performing EDs. METHODS: The CUREd Research Database was used for a retrospective observational study of all 1 039 251 attendances by 368 754 patients aged 75+ years in 18 type 1 EDs in the Yorkshire and the Humber region of England between April 2012 and March 2017. We estimated multilevel logit models, accounting for patients' characteristics and contact with emergency services prior to ED arrival, time variables and the ED itself. RESULTS: Patients in the oldest category (95+ years vs 75-80 years) were more likely to have a long ED wait (OR=1.13 (95% CI=1.10 to 1.15)), hospital admission (OR=1.26 (95% CI=1.23 to 1.29)) and ED reattendance (OR=1.09 (95% CI=1.06 to 1.12)). Those who had previously attended (3+ vs 0 previous attendances) were more likely to have long wait (OR=1.07 (95% CI=1.06 to 1.08)), hospital admission (OR=1.10 (95% CI=1.09 to 1.12)) and ED attendance (OR=3.13 (95% CI=3.09 to 3.17)). Those who attended out of hours (vs not out of hours) were more likely to have a long ED wait (OR=1.33 (95% CI=1.32 to 1.34)), be admitted to hospital (OR=1.19 (95% CI=1.18 to 1.21)) and have ED reattendance (OR=1.07 (95% CI=1.05 to 1.08)). Those living in less deprived decile (vs most deprived decile) were less likely to have any of these three outcomes: OR=0.93 (95% CI=0.92 to 0.95), 0.92 (95% CI=0.90 to 0.94), 0.86 (95% CI=0.84 to 0.88). These characteristics were not strongly associated with long waits for those who arrived by ambulance. Emergency call handler designation was the strongest predictor of long ED waits and hospital admission: compared with those who did not arrive by ambulance; ORs for these outcomes were 1.18 (95% CI=1.16 to 1.20) and 1.85 (95% CI=1.81 to 1.89) for those designated less urgent; 1.37 (95% CI=1.33 to 1.40) and 2.13 (95% CI=2.07 to 2.18) for urgent attendees; 1.26 (95% CI=1.23 to 1.28) and 2.40 (95% CI=2.36 to 2.45) for emergency attendees; and 1.37 (95% CI=1.28 to 1.45) and 2.42 (95% CI=2.26 to 2.59) for those with life-threatening conditions. We identified two EDs whose patients were less likely to have a long ED, hospital admission or ED reattendance than other EDs in the region. CONCLUSIONS: Age, previous attendance and attending out of hours were all associated with an increased likelihood of exceeding 4 hours in the ED, hospital admission and reattendance among patients over 75 years. These differences were less pronounced among those arriving by ambulance. Emergency call handler designation could be used to identify those at the highest risk of long ED waits, hospital admission and ED reattendance.

Within and between-day variation and associations of symptoms in Long Covid: Intensive longitudinal study.

BACKGROUND: People with Long Covid (Post Covid-19 Condition) describe multiple symptoms which vary between and within individuals over relatively short time intervals. We aimed to describe the real-time associations between different symptoms and between symptoms and physical activity at the individual patient level. METHODS AND FINDINGS: Intensive longitudinal study of 82 adults with self-reported Long Covid (median duration 12-18 months). Data collection involved a smartphone app with 5 daily entries over 14 days and continuous wearing of a wrist accelerometer. Data items included 7 symptoms (Visual Analog Scales) and perceived demands in the preceding period (Likert scales). Activity was measured using mean acceleration in the 3-hour periods preceding and following app data entry. Analysis used within-person correlations of symptoms pairs and both pooled and individual symptom networks derived from graphical vector autoregression. App data was suitable for analysis from 74 participants (90%) comprising 4022 entries representing 77.6% of possible entries. Symptoms varied substantially within individuals and were only weakly autocorrelated. The strongest between-subject symptom correlations were of fatigue with pain (partial coefficient 0.5) and cognitive difficulty with light-headedness (0.41). Pooled within-subject correlations showed fatigue correlated with cognitive difficulty (partial coefficient 0.2) pain (0.19) breathlessness (0.15) and light-headedness (0.12) but not anxiety. Cognitive difficulty was correlated with anxiety and light-headedness (partial coefficients 0.16 and 0.17). Individual participant correlation heatmaps and symptom networks showed no clear patterns indicative of distinct phenotypes. Symptoms, including fatigue, were inconsistently correlated with prior or subsequent physical activity: this may reflect adjustment of activity in response to symptoms. Delayed worsening of symptoms after the highest activity peak was observed in 7 participants. CONCLUSION: Symptoms of Long Covid vary within individuals over short time scales, with heterogenous patterns of symptom correlation. The findings are compatible with altered central symptom processing as an additional factor in Long Covid.

Study protocol for the Multiple Symptoms Study 3: a pragmatic, randomised controlled trial of a clinic for patients with persistent (medically unexplained) physical symptoms.

INTRODUCTION: Persistent physical symptoms (which cannot be adequately attributed to physical disease) affect around 1 million people (2% of adults) in the UK. They affect patients' quality of life and account for at least one third of referrals from General Practitioners (GPs) to specialists. These referrals give patients little benefit but have a real cost to health services time and diagnostic resources. The symptoms clinic has been designed to help people make sense of persistent physical symptoms (especially if medical tests have been negative) and to reduce the impact of symptoms on daily life. METHODS AND ANALYSIS: This pragmatic, multicentre, randomised controlled trial will assess the clinical and cost-effectiveness of the symptoms clinic intervention plus usual care compared with usual care alone. Patients were identified through GP searches and mail-outs and recruited by the central research team. 354 participants were recruited and individually randomised (1:1). The primary outcome is the self-reported Physical Health Questionnaire-15 at 52 weeks postrandomisation. Secondary outcome measures include the EuroQol 5 dimension 5 level and healthcare resource use. Outcome measures will also be collected at 13 and 26 weeks postrandomisation. A process evaluation will be conducted including consultation content analysis and interviews with participants and key stakeholders. ETHICS AND DISSEMINATION: Ethics approval has been obtained via Greater Manchester Central Research Ethics Committee (Reference 18/NW/0422). The results of the trial will be submitted for publication in peer-reviewed journals, presented at relevant conferences and disseminated to trial participants and patient interest groups. TRIAL REGISTRATION NUMBER: ISRCTN57050216.

Infection-competent monkeypox virus contamination identified in domestic settings following an imported case of monkeypox into the UK.

An imported case of monkeypox was diagnosed in December 2019 in a traveller returning from Nigeria to the UK. Subsequently, environmental sampling was performed at two adjoining single-room residences occupied by the patient and their sibling. Monkeypox virus DNA was identified in multiple locations throughout both properties, and monkeypox virus was isolated from several samples 3 days after the patient was last in these locations. Positive samples were identified following the use of both vacuum and surface sampling techniques; these methodologies allowed for environmental analysis of potentially contaminated porous and non-porous surfaces via real-time quantitative reverse transcriptase PCR analysis in addition to viral isolation to confirm the presence of infection-competent virus. This report confirms the potential for infection-competent monkeypox virus to be recovered in environmental settings associated with known positive cases and the necessity for rapid environmental assessment to reduce potential exposure to close contacts and the general public. The methods adopted in this investigation may be used for future confirmed cases of monkeypox in order to establish levels of contamination, confirm the presence of infection-competent material and to identify locations requiring additional cleaning.

Learning from COVID-19 related trial adaptations to inform efficient trial design-a sequential mixed methods study.

BACKGROUND: Many clinical trial procedures were often undertaken in-person prior to the COVID-19 pandemic, which has resulted in adaptations to these procedures to enable trials to continue. The aim of this study was to understand whether the adaptations made to clinical trials by UK Clinical Trials Units (CTUs) during the pandemic have the potential to improve the efficiency of trials post-pandemic. METHODS: This was a mixed methods study, initially involving an online survey administered to all registered UK CTUs to identify studies that had made adaptations due to the pandemic. Representatives from selected studies were qualitatively interviewed to explore the adaptations made and their potential to improve the efficiency of future trials. A literature review was undertaken to locate published evidence concerning the investigated adaptations. The findings from the interviews were reviewed by a group of CTU and patient representatives within a workshop, where discussions focused on the potential of the adaptations to improve the efficiency of future trials. RESULTS: Forty studies were identified by the survey. Fourteen studies were selected and fifteen CTU staff were interviewed about the adaptations. The workshop included 15 CTU and 3 patient representatives. Adaptations were not seen as leading to direct efficiency savings for CTUs. However, three adaptations may have the potential to directly improve efficiencies for trial sites and participants beyond the pandemic: a split remote-first eligibility assessment, recruitment outside the NHS via a charity, and remote consent. There was a lack of published evidence to support the former two adaptations, however, remote consent is widely supported in the literature. Other identified adaptations may benefit by improving flexibility for the participant. Barriers to using these adaptations include the impact on scientific validity, limitations in the role of the CTU, and participant's access to technology. CONCLUSIONS: Three adaptations (a split remote-first eligibility assessment, recruitment outside the NHS via a charity, and remote consent) have the potential to improve clinical trials but only one (remote consent) is supported by evidence. These adaptations could be tested in future co-ordinated 'studies within a trial' (SWAT).

Power Dynamics Among Health Professionals in Nigeria: A Case Study of the Global Fund Policy Process.

BACKGROUND: Health workers are central to health policy-making. Given health systems' complex, dynamic and political nature, various forms of 'hidden power' are at play as health workers navigate health systems. This study aims to explore the dynamics of power and its sources, and how this shapes policy-making and implementation within the Nigerian health systems context. METHODS: The case study was the Global Fund grant in Nigeria, and results are based on an in-depth qualitative study involving 34 semi-structured key informant interviews (KIIs), board-meeting observations, and documentary analysis conducted in 2014 and 2016. Participants held mid to senior-level positions (eg, Director, Programme Manager) within organisations involved with Global Fund activities, particularly proposal development and implementation. Data were analysed using thematic analysis in order to gain insight into the power dynamics of health professionals in policy processes. RESULTS: Medical professionals maintained dominance and professional monopoly, thereby controlling policy spaces. The structural and productive power of the biomedical discourse in policy-making encourages global actors and the local government's preference for rapid biomedical models that focus on medications, test kits, and the supply of health services, while neglecting aspects that would help us better understand the poor uptake of these services by those in need. The voices of the repressed groups (eg, non-clinical experts, patients and community based organisations) that better understand barriers to uptake of services are relegated. CONCLUSION: Professional monopoly theories help illustrate how medical professionals occupy and maintain an elite position in the health system of Nigeria. Structural and agential factors specific to the contexts are key in maintaining this professional monopoly while limiting the opportunities for other health occupations' rise up the social status ladder.

Frequent attendance at the emergency department shows typical features of complex systems: analysis of multicentre linked data.

OBJECTIVE: Frequent attendance at the ED is a worldwide problem. We hypothesised that frequent attendance could be understood as a feature of a complex system comprising patients, healthcare and society. Complex systems have characteristic statistical properties, with stable patterns at the level of the system emerging from unstable patterns at the level of individuals who make up the system. METHODS: Analysis of a linked dataset of routinely collected health records from all 13 hospital trusts providing ED care in the Yorkshire and Humber region of the UK (population 5.5 million). We analysed the distribution of attendances per person in each of 3 years and measured the transition of individual patients between frequent, infrequent and non-attendance. We fitted data to power law distributions typically seen in complex systems using maximum likelihood estimation. RESULTS: The data included 3.6 million attendances at EDs in 13 hospital trusts. 29/39 (74.3%) analyses showed a statistical fit to a power law; 2 (5.1%) fitted an alternative distribution. All trusts' data fitted a power law in at least 1 year. Differences over time and between hospital trusts were small and partly explained by demographics. In contrast, individual patients' frequent attendance was unstable between years. CONCLUSIONS: ED attendance patterns are stable at the level of the system, but unstable at the level of individual frequent attenders. Attendances follow a power law distribution typical of complex systems. Interventions to address ED frequent attendance need to consider the whole system and not just the individual frequent attenders.

Optimising the Conceptualisation of Context Comment on "Stakeholder Perspectives of Attributes and Features of Context Relevant to Knowledge Translation in Health Settings: A Multi-country Analysis".

Context matters. Therefore, efforts to develop greater conceptual clarity are important for science and practice. In this commentary, we outline some key issues that were prompted by Squire's et al.'s contribution. Specifically, we reinforce context as an interactive concept and therefore something that is hard to 'pin down', the problematic nature of conceptualising context in implementation and de-implementation, and a requirement for the development of culturally sensitive understandings. Finally, we suggest it is vital that continued investment into providing a more comprehensive list of determinants needs to be accompanied by an equal effort in developing practical methods and tools to support use and application.

Resistance narratives in patients' accounts of a mandatory pre-operative health optimisation scheme: A qualitative study.

Background: Pre-operative Health Optimisation is the engagement of patients in health behavior change, such as smoking cessation and weight reduction prior to surgery. Programmes which routinely delay surgery while some patients undergo preoperative optimisation are increasingly used within the UK. Advocates of this approach argue that it reduces perioperative risk and encourages longer term change at a teachable moment. However, critics have argued that mandatory preoperative optimisation schemes may perpetuate or exacerbate inequalities. Aim: To understand patients' experience of a mandatory preoperative optimisation scheme at the time of referral for elective surgery. Design and setting: Qualitative interview study in one area of the UK. Method: Participants were recruited through GP practices and participating weight-loss schemes. Data was collected from nine semi-structured face-to-face interviews. Thematic analysis was informed by the concept of narratives of resistance. Results: Four forms of resistance were found in relation to the programme. Interviewees questioned the way their GPs presented the scheme, suggesting they were acting for the health system rather than their patients. While interviewees accepted personal responsibility for health behaviors, those resisting the scheme emphasized that the wider system carried responsibilities too. Interviewees found referral to the scheme stigmatizing and offset this by distancing themselves from more deviant health behaviors. Finally, interviewees emphasized the logical contradictions between different health promotion messages. Conclusion: Patients described negative experiences of mandatory pre-operative health optimisation. Framing them as resistance narratives helps understand how patients contest the imposition of optimisation and highlights the risk of unintended consequences.